Associate Director, Health Authorities

ImmunityBio•Summit, NJ

18d•Onsite

About The Position

The Associate Director, Health Authorities will aid the advance of global clinical regulatory compliance for investigational and marketed products and manage the preparation, review, and finalization of submission packages and responses to Health Authorities. This position will contribute to the preparation of INDs, CTAs, BLAs, MAAs, and any other application for health authorities in line with local requirements.

Requirements

Bachelor’s Degree in life sciences or technical discipline with 10+ years of relevant progressive experience required; or Master’s Degree in life sciences or technical discipline with 8+ years of relevant progressive experience required; or Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience required.
Experience managing staff required
Experience in the management and preparation of the submission of clinical modules in eCTD format required.
Experience in medical writing
Experience with organizing responses to Health Authority information requests required.
Expert knowledge of Health Authority guidance documents and requirements
Strong leadership skills with the ability to direct and develop professional staff
Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines
Expert knowledge of clinical documentation
Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
Strong organizational skills, written and oral communication skills, and attention to detail
Ability to successfully manage multiple changing deadlines and operate in ambiguity

Nice To Haves

Experience with regulatory submissions outside of the US preferred

Responsibilities

Lead Health Authorities direct reports by delegating projects, establishing and meeting timelines, and ensuring high quality work products
Manage the day-to-day activities of staff to include the hiring and training of new team members, coaching employees and monitoring performance.
Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, data management plan, and any other clinical trial associated document
Provide input to the design and reporting of clinical studies sponsored by IBRX
Manage the preparation of the relevant clinical sections of written summaries for regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and any other applications.
Create and maintain project plans for health authorities operations
Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies
Lead external stakeholder engagement throughout the submission lifecycle, coordinating with CROs, external regulatory consultants, and subject matter experts / key opinion leaders to gather data, craft high‑quality RFI responses, and foster constructive agency relationships
Prepare and assign responses to Health Authority comments and questions pertaining to clinical issues.
Maintain timelines on responses and assemble the final, completed submission package.
Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications
Ensure continuous monitoring of, and incorporation of, the most recent regional and local health‑authority guidances; interpret amendments and apply updated requirements to all regulatory dossiers to mitigate agency queries and preserve submission integrity
Oversee version‑control governance by supervising a centralized document repository, defining naming‑convention standards, authorizing change‑tracking procedures, and approving final module versions prior to electronic upload to ensure audit‑ready documentation
Develop and maintain product‑development road maps based on projected approval dates
Performs ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities.

Benefits

This position is eligible for a discretionary bonus and equity award.
Medical, Dental and Vision Plan Options
Health and Financial Wellness Programs
Employer Assistance Program (EAP)
Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
Healthcare and Dependent Care Flexible Spending Accounts
401(k) Retirement Plan with Company Match
529 Education Savings Program
Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
Paid Time Off (PTO) includes: 11 Holidays
Exempt Employees are eligible for Unlimited PTO
Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day